Biotechnology & Medical Research

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CareDx, Inc gives FY 2014 revenue guidance above analysts' estimates

Wednesday, 27 Aug 2014 04:01pm EDT

CareDx, Inc:Expects revenue for FY 2014 to be in the range of $26 to $26.5 million.FY 2014 revenue of $25.6 million - Thomson Reuters I/B/E/S.

Innate Pharma SA announces that the European Commission has granted orphan drug designation to IPH4102

Wednesday, 27 Aug 2014 01:32am EDT

Innate Pharma SA:Announces that the European Commission has granted orphan drug designation to IPH4102 for the treatment of cutaneous T-cell lymphoma (CTCL).Says IPH4102 is a cytotoxic anti-KIR3DL2 antibody, aiming at destroying CTCL cancer cells.Says Phase I trial with IPH4102 is expected to begin in 2015.

Actinogen Ltd to acquire Corticrine Limited

Tuesday, 26 Aug 2014 11:00pm EDT

Actinogen Ltd:Says that it has signed a sale and purchase agreement to acquire 100 pct. of Corticrine Ltd, a pharmaceutical company focused on the development of new therapies for Alzheimer’s dementia.

D.Western Therapeutics Institute Inc announces negative phase two trial result of K-134

Tuesday, 26 Aug 2014 10:30pm EDT

D.Western Therapeutics Institute Inc:Announces negative phase two trial result of K-134, which is a antiplatelet drug.The phase two trial began with curing intermittent claudication patients with arteriosclerosis obliterans from Dec. 2011 and can not achieves the primary evaluation items.Announces have difficulty to begin phase three trial.

Alkermes announces initiation of phase 1 clinical study of ALKS 7106 for treatment of pain

Tuesday, 26 Aug 2014 07:00am EDT

Alkermes PLC:Says initiation of phase 1 clinical study of ALKS 7106, proprietary, novel, oral, small-molecule drug candidate for the treatment of pain.The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults.ALKS 7106 represents a new class of analgesic agents in development at Alkermes: potent opioid modulators designed for treatment of pain with intrinsically low potential for abuse and overdose death - two liabilities associated with opioid analgesics.ALKS 7106's potential attributes derive from its intrinsic mechanism of action in the brain rather than through the use of abuse-deterrent technologies or formulations.This phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose, multi-cohort, four-week study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 administered orally in about 80 healthy, male adults.Results from this phase 1 study are expected in the first half of 2015.

Ebola Vaccine using ImmunoVaccine Inc's DepoVax proves highly efficacious in non-human primate study

Monday, 25 Aug 2014 10:30am EDT

ImmunoVaccine Inc:Says positive results for vaccine formulated in DepoVax technology in Ebola virus challenge study performed by National Institute of Allergy and Infectious Diseases (NIAID) of National Institutes of Health (NIH).In preliminary study using cynomolgus monkeys, which are particularly sensitive to Ebola virus, all vaccinated subjects survived exposure to lethal dose of the wild type Zaire strain of the virus. All unvaccinated control animals succumbed to disease.In this study four cynomolgus macaque subjects received two doses of DepoVax-formulated vaccine, one at study initiation and second on Day 56.They were then challenged on day 70 with lethal dose of wild type Zaire strain of Ebola virus.Zaire strain is believed to be most lethal among Ebola viruses and is responsible for current Ebola virus outbreak.More than two weeks following exposure to virus, all vaccinated subjects were alive with no disease symptoms.Two control animals in this study succumbed to infection within seven days.This study, conducted under NIAID's preclinical services program (HHSN272201200003I/HHSN27200008, HHSN272201000006I/HHSN27200007), was designed to identify favorable vaccine candidates for further study.Based on this high efficacy observed in cynomolgus macaques, Immunovaccine is exploring a potential development program for Ebola virus vaccine with various organizations.

Vaccinogen completes initial closing of $80 mln financing and announces management changes

Monday, 25 Aug 2014 07:00am EDT

Vaccinogen Inc:Completes the initial closing of a private placement of $80 mln of units and common stock.Vaccinogen received gross proceeds of $10 mln in this first closing.Says Benjamin S. Carson has been appointed to the Board of Directors and named Chairman of the Board.Appoints co-founder and President Andrew L. Tussing, as Chief Executive Officer to replace Michael G. Hanna.Hanna will continue to serve as a director and will now be Chairman Emeritus.

Insys Therapeutics receives FDA Orphan Drug Designation for Pharmaceutical Cannabidiol

Monday, 25 Aug 2014 07:00am EDT

Insys Therapeutics Inc:Says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM).Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S.

Alkermes PLC submits New Drug Application to FDA for Aripiprazole Lauroxil for treatment of Schizophrenia

Monday, 25 Aug 2014 07:00am EDT

Alkermes PLC:Submits a New Drug Application to the U.S. Food and Drug Administration for approval of aripiprazole lauroxil for the treatment of schizophrenia.Data submitted as part of this NDA include the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo.

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